Dialysis valve and method

ABSTRACT

A dialysis valve includes a tube attached between an artery and a vein which, when elongated, simultaneously narrows in diameter at at least one location. The narrowed portion of the tube decreases the volume and velocity between the arterial and venous side of the patient to prevent damage or intimal hyperplasia on the venous side between dialysis treatments. When the valve is opened for dialysis, an unrestricted blood flow exists between the arterial and venous side, permitting a controlled, open blood flow during dialysis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 15/046,070 filed Feb. 17, 2016 (now U.S. Pat. No. 10,046,103), whichis a continuation of U.S. application Ser. No. 14/153,563 filed Jan. 13,2014 (now U.S. Pat. No. 9,295,774), which is a continuation of U.S.application Ser. No. 13/204,445, filed on Aug. 5, 2011 (now U.S. Pat.No. 8,628,502) by Timothy Claude et al., entitled “Dialysis Valve andMethod,” which is a continuation application of U.S. application Ser.No. 12/877,806, filed on Sep. 8, 2010 (now U.S. Pat. No. 8,012,134) byTimothy Claude et al., entitled “Dialysis Valve and Method,” which is acontinuation of U.S. application Ser. No. 12/431,101, filed on Apr. 28,2009 (now U.S. Pat. No. 7,811,264) by Timothy Claude et al., entitled“Dialysis Valve and Method,” which is a continuation of U.S. applicationSer. No. 10/497,137, filed on Aug. 18, 2004 (now U.S. Pat. No.7,540,859) by Timothy Claude et al., entitled “Dialysis Valve andMethod,” which is a continuation of PCT Application No.PCT/US/2004/012438, filed Apr. 22, 2004, by Interrad Medical Inc.,entitled “Dialysis Valve and Method,” which claims priority to U.S.Provisional Application Ser. No. 60/464,778, filed Apr. 23, 2003 byClaude et al, entitled “Valve,” the contents of which are fullyincorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to a valve useful for controlling bloodflow in artificial dialysis fistulas or bypass grafts.

BACKGROUND

Dialysis involves connecting patients with insufficient kidney functionto a dialysis machine which cleanses the blood of waste products andimpurities. Put another way, the dialysis machine performs the samefunction as a normal, healthy kidney should. In other cases, dialysis isused to remove poisons and drugs from the blood more safely and quicklythan the natural kidneys would. To properly connect a patient to adialysis machine requires accessing, on a continuing basis, a bloodvessel, to divert the flow of blood from the patient to the dialysismachine. This is normally accomplished by the implantation into thepatient of an artificial fistula or bypass graft, which is usually madeof expanded polytetrafluoroethylene (ePTFE). In the case of a graft, thegraft is punctured with a needle and blood from patients requiringdialysis is transported to the dialysis machine whereupon the blood isdiffused across a semipermeable membrane. Upon completion of thisprocedure, dialyzed blood is returned to the patient through a secondneedle in the graft. Dialysis is usually necessary every two to threedays, which often results in the lumen of the graft becomingcompromised. The more common problem related to dialysis grafts isintimal hyperplasia, which can occur when the higher pressure/volume ofthe arterial flow crosses the boundary from the relatively non-compliantgraft to the more compliant outflow vein at the venous anastomosis. Theresultant intimal hyperplasia in the vein adjacent to the anastomosisleads to progressive stenosis and eventually premature clotting andgraft occlusion. Repairing a hemodialysis graft occlusion is currentlyaccomplished by one of several techniques: open surgical revision(surgical thrombectomy), thrombolytic drugs (thrombolysis) or mechanicaldeclotting via percutaneous techniques (percutaneous mechanicalthrombectomy). Percutaneous mechanical thrombectomy techniques includesuction thrombectomy, balloon thrombectomy, clot maceration andmechanical thrombectomy. The goal of each of these therapies is thepreservation of vascular access. In almost all cases, any techniquewhich is used to declot the graft will also require angioplasty of thevenous anastomotic stenosis in order to reestablish normal flow.

It is known that blood flow in excess of 300 cc per minute can causeintimal hyperplasia in the outflow vein near the anastomosis. Theproblem arises from the fact that blood flows less than 300 cc perminute have been associated with graft thrombosis. The solution to thisdilemma appears to arise from a recognition that blood flows of lessthan 300 cc per minute are not intrinsically pro-thrombotic, but are areflection of progressive stenosis that is likely to rapidly reach alevel at which thrombosis can occur with any added insult. What would beideal and what is clearly needed is a method for preventing high flowsthrough the graft while it is not being used and thus reducing oreliminating the stimulus for intimal hyperplasia and yet allowing thehigh flows through the graft during dialysis that are required for asuccessful dialysis run.

SUMMARY

In one embodiment the invention comprises a method of controlling bloodflow during dialysis. The method involves implanting a tube between apatient's vein and an artery, where the tube is capable of containingfluids and defines a longitudinal dimension, a diameter and an innersurface. The diameter of the tube is narrowed during dialysis at atleast one location along the longitudinal dimension to control thevolume and velocity of blood flow through the tube during dialysis. Inanother embodiment, the inner surface of the tube at the narrowedlocation is in a substantially circular configuration.

In another embodiment the invention comprises a dialysis valve, thevalve comprising a tube capable of containing fluids and defining alongitudinal dimension, a diameter and an inner surface. A bellowscapable of being held at varying lengths defines an interior chamberwherein the tube is mounted in the chamber so that when the bellowsincreases in length, the tube simultaneously increases in longitudinaldimension and at least a portion of the tube decreases in diameter. In afurther embodiment the tube comprises a braided nitinol structureprocessed to exhibit superelasticity below normal human body temperaturecoated with an elastomer allowing the tube to be repeatedly altered inlongitudinal dimension and in diameter and still maintain fluidcontaining capability.

In still another embodiment the invention comprises a dialysis valve,the valve comprising a tube capable of containing fluids and defining alongitudinal dimension, a diameter and an inner surface. A ballooncontacts the tube so that when the balloon is inflated at least aportion of the tube decreases in diameter. In a further embodiment, thetube comprises a braided nitinol structure processed to exhibitsuperelasticity below normal human body temperature coated with anelastomer allowing the tube to be repeatedly altered in longitudinaldimension and in diameter and still maintain fluid containingcapability. In yet a further embodiment the balloon surrounds the tube.

In an alternative embodiment the invention comprises a valve, the valvecomprising a tube capable of containing fluids and defining alongitudinal dimension, a diameter and an inner surface. A nitinolspring is attached to each end of the tube so that when the spring isactuated the tube decreases in longitudinal dimension and the tubeincreases in diameter. In a further embodiment the tube comprises abraided nitinol structure processed to exhibit superelasticity belownormal human body temperature coated with an elastomer allowing the tubeto be repeatedly altered in longitudinal dimension and in diameter andstill maintain fluid containing capability.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of the uncoated braid in the truncated, openconfiguration.

FIG. 1a shows an end view of the uncoated braid shown in FIG. 1.

FIG. 2 shows a side view of the uncoated braid in the elongated,decreased diameter configuration.

FIG. 2a shows an end view of the uncoated braid shown in FIG. 2.

FIG. 3 shows a side view of the coated braid assembly in the shortened,increased diameter configuration.

FIG. 3a shows an end view of the coated braid assembly shown in FIG. 3.

FIG. 4 shows a side view of the coated braid assembly in the elongated,decreased diameter configuration.

FIG. 4a shows an end view of the coated braid assembly shown in FIG. 4.

FIG. 5 shows a cross section of the coated braid assembly shown in FIGS.3, 3 a, 4, and 4 a.

FIG. 6 shows a cut away plan view of the dialysis valve actuated by anelongatable/compressible bellows in the elongated, closed position.

FIG. 6a shows a cut away plan view of the dialysis valve shown in FIG. 6in the shortened, open position.

FIG. 6b shows a side view of the valve shown in FIG. 6.

FIG. 6c shows a plan view of the valve shown in FIG. 6.

FIG. 6d shows an end view of the valve shown in FIG. 6.

FIG. 7 shows a cut away plan view of the valve activated by aninflatable balloon.

FIG. 7a shows a side view of the dialysis valve shown in FIG. 7, withthe infusion needle penetrating the membrane.

FIG. 8a shows a cut away side view of the valve with a nitinol coilspring in the elongated, narrowed configuration.

FIG. 8b shows a cut away side view of the valve with a nitinol coilspring in the shortened, open configuration.

FIG. 8c is a partial breakaway side view of the nipple and threadedmember attached to the coated braid assembly.

FIG. 9 shows a plan view of an embodiment of the valve sutured between avein and an artery.

DETAILED DESCRIPTION Definitions

“Braid Assembly” refers to a tubular structure comprised of overlappingflexible strands.

“ePTFE” refers to Expanded Polytetrafluoroethylene.

NOMENCLATURE

-   10 Uncoated Braid-   11 Strand-   12 Diameter-   14 Longitudinal Dimension-   20 Coated Braid Assembly-   22 Diameter-   24 Longitudinal Dimension-   25 Inner Surface-   26 Elastomeric Coating-   28 Anti-Thrombogenic Coating-   30 Fistula Graft (Arterial Side)-   31 Bonding Area-   32 Fistula Graft (Venous Side)-   41 Aperture-   42 Outer Housing-   43 Chamber-   44 Bellows-   45 Inter-Wall Space of Bellows-   46 Hydraulic Line-   47 Inner Wall of Bellows-   48 Port-   49 Membrane-   50 Dialysis Valve (Hydraulic Bellows Actuated)-   51 Outer Wall of Bellows-   52 Infusion Needle-   53 Nipple-   54 Floating Connector-   55 Fixed Connector-   56 Compressible Section-   60 Dialysis Valve (Hydraulic Balloon Actuated)-   62 Balloon-   64 Hydraulic Line-   80 Valve-   82 Nitinol Spring-   83 O Ring-   84 Controller-   84 a Electrical Wire (Signal)-   84 b Electrical Wire (Ground)-   85 Threaded Connector-   86 Outer Housing-   100 Arm-   110 Artery-   120 Vein    Construction

The valve of the present invention applies the principles of fluiddynamics so that as the lumen of a tube is narrowed, the dynamicpressure and volume of fluids passing through it will decrease. Thus,when the principles of fluid dynamics are applied to blood flow, acontrolled narrowing in a synthetic dialysis graft decreases arterialdynamic pressure and decreases blood volume in the coated braid assembly20 before it can impact the lower pressure venous volume in thereceiving vein 120. It has been medically documented that a blood flowrate of below 300 cc per minute will, in most cases, prevent intimalhyperplasia from occurring. An additional advantage of reducing bloodflow rate to below 300 cc per minute is that it further reduces thelikelihood of problems with peripheral “stealing” of blood from theextremity (e.g., the hand) during the dialysis procedure.

FIGS. 1, 1 a, 2 and 2 a show an uncoated tubular braid 10 which definesa diameter 12 and a longitudinal dimension 14. The braid 10 comprises aplurality of individual strands 11 that are crossed over each other toform a cylinder as shown in FIG. 1 when in an unstressed or relaxedstate. The diameter 12 and longitudinal dimension 14 of the braid 10 areinversely proportional to each other, wherein as shown in FIG. 2 thebraid 10 upon being increased in its longitudinal dimension 14 decreasesin at least some portion of its diameter 12. Conversely, as shown inFIG. 1, when the braid 10 is decreased in longitudinal dimension 14 thediameter 12 increases. The braiding pattern as shown in FIGS. 1, 1 a, 2and 2 a shows bilateral symmetry wherein a center portion (unnumbered)of the braid 10 decreases in diameter with an increased longitudinaldimension 14. It should be noted, however, that other braidingtechniques exist which would cause a different portion (not shown) ofthe braid 10 to decrease in diameter 12 with an increased longitudinaldimension 14, resulting in a different symmetry. In a preferredembodiment, the braid 10 is made of nitinol strands 11. Nitinol ispreferred because of its excellent biocompatibility and more importantlyits ability to be repeatedly deformed and reformed without taking apermanent set or kink or breaking due to fatigue resistance. Othermaterials contemplated by and therefore within the scope of theinvention include various grades of stainless steel and compositematerials.

FIGS. 3, 3 a, 4, 4 a and 5 show a coated braid assembly 20 which definesa diameter 22 and a longitudinal dimension 24. The coated braid assembly20 comprises a plurality of individual strands 11 that are crossed overeach other to substantially form a cylinder as shown in FIG. 3 when inan unstressed or relaxed state. In a preferred embodiment, the coatedbraid assembly 20 is made of individual strands 11 of nitinol which isprocessed to display superelasticity at some point below normal humanbody temperature of 37 degrees C. Additional materials such as carbonfibers, stainless steel and composite materials would also work and aretherefore within the scope of the invention. The coated braid assembly20 is coated with an elastomeric coating 26 which serves to form asealed tube capable of containing and conveying fluids. The diameter 22and longitudinal dimension 24 of the coated braid assembly 20 areinversely proportional to each other, wherein as shown in FIG. 4 thecoated braid assembly 20 upon being increased in its longitudinaldimension 24 decreases in at least some portion of its diameter 22.Inversely, as shown in FIG. 3, when the coated braid assembly 20 isdecreased in longitudinal dimension 24 the diameter 22 of the previouslynarrowed portion (unnumbered) increases. The braiding pattern as shownin FIGS. 3, 3 a, 4 and 4 a shows bilateral symmetry wherein a centerportion (unnumbered) of the coated braid assembly 20 decreases indiameter with an increased longitudinal dimension 24. It should be notedthat other braiding techniques and materials exist which would cause adifferent portion (not shown) of the coated braid assembly 20 todecrease in diameter 22 with an increased longitudinal dimension 24,resulting in a different symmetry.

FIG. 5 shows a cross section of the coated braid assembly 20. Theindividual strands 11 of the coated braid assembly 20 are embedded inthe elastomeric coating 26 which serves to bind the individual strands11 together as well as sealing the cylinder formed by the strands 11 toform a sealed tube (unnumbered) capable of containing and conveyingfluids. The interior surface 25 of the coated braid assembly 20 isfurther coated with an anti-thrombogenic coating 28 or apro-endothelialization coating (not shown) which mimics theendothelialization which is part of the blood vessel's initmal liningand prevents or reduces blood clotting. Various substances can be usedas anti-thrombogenic coating 28 in the present invention, including butnot limited to heparin complex solutions, benzalkonium heparinate,tridodeclymethylammonium heparinate, chlorhexidine-silver sulfadiazine,mycocycline and rifampin. The elastomeric coating 26 can comprise manymaterials, such as a urethane, ePTFE or silicone material, which providegreat strength and flexibility while remaining thin. The elastomericcoating 26 is applied to the uncoated braid 10 by any of several coatingmethods well known to those having ordinary skill in the art, includingbut not limited to, dipping, spraying, injection molding and coatingover a mandrel to produce a smooth inner surface 25 of the coated braidassembly 20 prior to applying the anti-thrombogenic coating 28.Similarly, the anti-thrombogenic coating 28 can be applied by coating,spraying, dipping or vapor deposition processes.

FIG. 6 shows a cut away plan view of an embodiment of the dialysis valve50 actuated by a hydraulically actuated double walled metal bellows 44.The bellows 44 can be made of such materials as platinum, gold orstainless steel and can be made by vapor deposition over a wax mandrel.Two separate sized mandrels are used to produce a (smaller diameter)inner wall 47 and a (slightly larger diameter) outer wall 51. Siliconeor urethane glue (not shown) is applied to a nipple 53 at a bonding area31 extending from a floating connector 54 and/or fixed connector 55. Thecoated braid assembly 20 is then attached to the floating connector 54and/or fixed connector 55 by inserting the coated braid assembly 20 overthe nipple 53 extending from the floating connector 54 and/or fixedconnector 55. The surface (unnumbered) of the nipple 53 may be knurledor have concentric grooves to facilitate attachment and sealing. An “O”ring 83 may be placed over the end (unnumbered) of the coated braidassembly 20 contacting the nipple 53 to further facilitate attachmentand sealing. The coated braid assembly 20 with attached floatingconnector 54 and/or fixed connector 55 is then mounted inside a chamber43 formed by the inner wall 47 of the bellows 44. At least one end(unnumbered) of the coated braid assembly 20 is attached to a floatingconnector 54. The floating connector 54 and/or fixed connector 55provide that the ends (unnumbered) of the coated braid assembly 20 aremaintained in an open configuration irrespective of the diameter ofother portions of the coated braid assembly 20. It is contemplated tohave both ends (unnumbered) of the coated braid assembly 20 attached toa floating connector 54. Alternatively, one end (unnumbered) of thecoated braid assembly 20 can be attached to a floating connector 54while the other end (unnumbered) is attached to a fixed connector 55.The inner wall 47 is inserted into the outer wall 51 and thenlaser-welded at the end (unnumbered) to a floating connector 54 at eachend or a floating connector 54 at one end and a fixed connector 55 atthe other end to seal the bellows 44. The floating connector 54 andfixed connector 55 are made of the same material as the inner wall 47and outer wall 51 of the bellows 44. A hydraulic line 46 is attached toan aperture 41 extending through the outer wall 51 only. An inter-wallspace 45 exists between the inner wall 47 and outer wall 51 of thebellows 44. In the view shown in FIG. 6 the coated braid assembly 20 andfloating connectors 54 are disposed inside the chamber 43. In FIG. 6 thebellows 44 is longitudinally extended, which correspondingly increasesthe longitudinal dimension of the internally attached coated braidassembly 20. As shown in FIG. 4 when the coated braid assembly 20 islongitudinally extended at least a portion of it will assume a lesserdiameter 22. It should be mentioned that the diameter 22 of the coatedbraid assembly 20 is dependent on its degree of longitudinal extension.The double walled bellows 44 is mounted in an outer housing 42 which isconfigured to provide space for the coated braid assembly 20 to elongateor shorten during actuation of the valve 50. Due to the varyinglongitudinal dimensions 24 the coated braid assembly 20 can assume, acompressible section 56 made of ePTFE is attached to the at least onefloating connector 54. Alternately, if two floating connectors 54 areused, a second compressible section 56 will be used. One end(unnumbered) of the coated braid assembly 20 and attached floatingconnector 54 or fixed connector 55 is attached to compressible section56 which is attached to the fistula graft (arterial) 30 while the otherend (unnumbered) is attached to the fistula graft (venous) 32 or to asecond compressible section 56. A bonding area 31 exists where anadhesive is alternatively used to further facilitate the attachment. Thefistula grafts 30, 32 are made of ePTFE. A hydraulic line 46 is in fluidcommunication with the inner wall space 45 of the bellows 44 via theaperture 41 and extends to a port 48 which is covered by a membrane 49which is made of a self-sealing material such as an implantable latex,urethane or silicone. The outer housing 42 is preferably injectionmolded implantable high durometer urethane plastic (Carbothane®) ormachined stainless steel or other biocompatible plastic and metalmaterials could also be used. During actuation of the dialysis valve 50a saline solution (not shown) is injected into the bellows 44 by meansof a pressurizing infusion needle 52 which is inserted by a physicianthrough the membrane 49 covering the port 48 via the hydraulic line 46.The bellows 44 is adjustable corresponding to the amount of salineinjected and can thus be fully extended or assume any intermediateposition. This causes the bellows 44 to extend longitudinally, thussimultaneously causing the coated braid assembly 20 to increase inlongitudinal dimension 24 and at least a portion to decrease in itsdiameter 22, resulting in a controlled, reduced blood volume through thevalve 50. The normal, default condition of the bellows 44 is in theforeshortened or open configuration as shown in FIG. 6a . Thus, shouldcontrol of blood flow through the dialysis valve 50 fail for any reason,normal blood flow would resume.

FIG. 6a shows a cut away plan view of the dialysis valve 50 shown inFIG. 6 but with the coated braid assembly 20 in the shortened, openconfiguration.

FIG. 6b shows a side view of the dialysis valve 50. FIG. 6c shows a topview of the dialysis valve 50. FIG. 6d shows an end view of the dialysisvalve 50.

FIG. 7 shows a cut away plan view of an embodiment of the dialysis valve60 which is actuated by means of a hydraulic balloon 62 which extendsaround the coated braid assembly 20 in a cuff-like manner. The balloon62 can be made from elastomeric latex, silicone or urethane. In thisembodiment of the dialysis valve 60 the coated braid assembly 20 isattached at each end to a floating connector 54. The floating connector54 provides that the ends (unnumbered) of the coated braid assembly 20are maintained in an open configuration regardless of the diameter ofother portions of the coated braid assembly 20. The floating connector54 is attached at at least one end to a compressible section 56 made ofePTFE within the outer housing 42. The compressible section 56 isattached to the floating connector 54 and provides for the increase ordecrease of the longitudinal dimension 24 of the coated braid assembly20 within the outer housing 42 during actuation of the valve 60. Itshould be mentioned that both ends of the coated braid assembly 20 maybe provided with floating compressible sections 56. A port 48 isattached to the outer housing 42 and is covered by a membrane 49 whichis made of a self-sealing material such as silicone or urethane. Theouter housing 42 is preferably injection molded implantable highdurometer urethane plastic or machined stainless steel, however, otherbiocompatible plastic and metal materials could also be used. Ahydraulic line 64 connects balloon 62 to the port 48 which is covered bymembrane 49. Actuation of the dialysis valve 60 is accomplished as shownin FIG. 7a by inserting an infusion needle 52 through the membrane 49and injecting a pressurized saline solution (not shown) through the port48 via the hydraulic line 64. The balloon 62 is adjustable correspondingto the amount of saline injected and can thus be fully inflated orassume any intermediate position. When the balloon 62 is mounted withinthe outer housing 42 this results in the balloon 62 radially expandingas well as elongating, which causes at least a portion of the coatedbraid assembly 20 to assume a decreased diameter 22, thus controllingthe flow of blood through the dialysis valve 60. Radial compression isthus increased, precisely controlling the inward force of the inflatedballoon 62 against the hemo-dynamic forces exerted against the innersurface 25 of the coated braid assembly 20. It should also be mentionedthat in another embodiment, the balloon 62 and coated braid assembly 20could be integrally attached at one or a plurality of locations (notshown).

FIG. 7a shows a side view of the dialysis valve 60 with the infusionneedle 52 penetrating the membrane 49. Also shown in FIG. 7a is theconnection of the hydraulic line 64 to the balloon 62.

FIG. 8a shows a cut away side view of an embodiment of the valve 80 thatis actuated by a nitinol spring 82 attached to at least one floatingconnector 54. The floating connector(s) 54 and/or fixed connector 55is/are attached to each end (unnumbered) of the coated braid assembly 20and serve as attachment points for the nitinol spring 82 as well askeeping the ends (unnumbered) of the coated braid assembly 20 in an openconfiguration at all times. Silicone or urethane glue (not shown) isapplied at a bonding area 33 to a nipple 53 extending from the floatingconnector 54 and/or fixed connector 55. The coated braid assembly 20 isthen attached to the floating connectors 54 by inserting the coatedbraid assembly 20 over the nipple 53 extending from the floatingconnector 54 and/or fixed connector 55. The surface (unnumbered) of thenipple 53 may be knurled or have grooves to facilitate attachment andsealing. A slip ring or “0” ring 83 may further be placed over the end(unnumbered) of the coated braid assembly 20 contacting the nipple 53 tofurther facilitate attachment and sealing. At least one end of thenitinol spring 82 and attached floating connector 54 is attached to acompressible section 56 of ePTFE to provide for longitudinal movement ofthe coated braid assembly 20 during actuation within the outer housing86. At least one floating connector 54 is threadably engaged with athreaded connector 85 which serves to provide a means of adjustment forthe amount of closure of the valve 80. A controller 84 which comprisesan electrical power supply (not shown), regulator (not shown) and timer(not shown) is in electrical connection by means of signal wire 84 a andground wire 84 b to respective ends of the nitinol spring 82. In apreferred embodiment, the electrical energy needed for actuating thenitinol spring 82 is supplied by a battery (not shown). Battery power ispreferred because of portability, safety and low cost. When anappropriate amount of electrical energy is sent from the controller 84to the nitinol spring 82 it will shorten from its default elongated(closed) configuration as shown in FIG. 8a , to its shortened (open)configuration as shown in FIG. 8b , thus causing a increased diameter 22of the coated braid assembly 20 and an open flow through the valve 80.

FIG. 9 shows a plan view of the dialysis valve 50 implanted into the arm100 of a patient between an artery 110 and vein 120 to perform dialysis.While the dialysis valve 50 is shown in FIG. 9, the other embodimentsare disclosed in the specification and would be implanted in the patientin an identical manner.

Nitinol is an approximate stoichiometric alloy of nickel and titaniumand is used in the invention for two different purposes, as discussedabove. Other elements, however, such as vanadium are sometimes added insmall amounts to alter the mechanical characteristics of the alloy.Chemical composition and processing history primarily determine theparticular mechanical properties of a shape memory/superelastic metallicalloy. In general, such an alloy will exist in either one or the other,or combinations of two crystallographic phases. Austenite is the parentcrystallographic phase and exists at higher temperatures. Martensite isthe other phase and is formed by either subjecting the alloy to lowertemperatures, electrical stress or by placing mechanical or physicalstress on the alloy while it is in the austenitic phase. Transitiontemperatures between these two phases can be experimentally determinedfor a particular alloy. Processing history includes high temperatureannealing as well as low temperature forming and deformation. Followingstandard material and processing specifications, the transitionaltemperatures that define the alloy's mechanical characteristics arepredictable and controllable. Standard transitional temperaturedesignations are given as: M_(s) for the start of the transition to themartensitic phase, M_(f) for completion of the transition to martensite,A_(s) for the start of the transition to the austenitic phase, and A_(f)for the completed transition to austenite.

Nitinol is trained into a desired shape by restraining the alloy intothe desired shape, then baking the restrained alloy at relatively hightemperatures for a specified period of time. Due to the variability incomposition, desired mechanical characteristics and size of alloy used,temperatures and times will vary and overlap.

Superelasticity is based on the stress-induced phase transition fromaustenite to martensite. Stress-induced induced phase transition fromaustenite to martensite occurs when the alloy temperature is above A_(f)and a physical restraint is applied to the alloy. As long as therestraint is in place, the portion of the alloy receiving the stressreverts to the martensitic phase, which remains as long as the stress ismaintained. Unless the shape recovery limits are exceeded, when therestraint is removed and the stress is released the alloy returns to itsoriginal austenitic phase and trained shape as long as the temperatureis maintained above A_(f). Thus, when the austenitic, trained shape ofthe alloy is deformed and held by stress in a new shape, a certainamount of force is exerted by the alloy against the restraint as itresists the new, untrained shape.

The thermal shape memory effect of these alloys has been known muchlonger than superelasticity. Thermal shape memory occurs as the resultof a piece of shape memory alloy metal being deformed while in the lowertemperature martensitic phase and then being reheated to a temperaturesomewhere above A_(s) which causes the alloy to reform in the austeniticphase. When the crystallographic nature of the alloy is completelyaustenitic, the alloy's shape returns to the previously trained shape.Shape memory training occurs when a thermal shape memory/superelasticmetallic alloy is annealed (heat treated) while restrained in a certainshape. The trained shape will then be maintained unless it is deformedwhile in the low temperature martensitic phase. Upon reheating the alloyto the austenitic phase, the original shape, which was “learned” in theannealing process, will be “remembered” and returned to. Thus,temperature change is one way of controlling the crystallographic phaseof a shape memory/superelastic metallic alloy. The nitinol spring 82 isactuated by electrical energy heating the alloy to resume the austeniticphase and thus its originally trained shape.

One practical advantage of a shape memory/superelastic alloy overnon-superelastic materials is that it can be deformed to a far greaterdegree without taking a permanent set or kink. In the case ofsuperelastic alloys (i.e., alloys processed to exhibit superelasticityat body temperature), assuming the alloy is above the A_(f) temperature,removal of the restraint alone is sufficient to resume the original,trained shape. When the alloy is processed to have shape memorycharacteristics, the martensitic phase alloy need only be subjected totemperatures somewhere above A_(f) and the alloy will eventually returnto its original, trained shape. It is also possible to use a restraintin conjunction with alloys trained to exhibit thermal shape memorycharacteristics.

Thus, the uncoated braid 10 that forms the reinforcement of the coatedbraid assembly 20 made of nitinol is processed to exhibit superelasticcharacteristics at human body temperature. More specifically,superelasticity (stress-induced martensite) allows the coated braidstructure 20 to repeatedly increase and decrease its longitudinaldimension 24 while simultaneously decreasing and increasing its diameter22 without taking a permanent set or kink. Finally, breaking as a resultof metal fatigue is virtually unknown with superelastic nitinol.

Use

The dialysis valve 50, 60 is incorporated into a dialysis fistula systemto close or limit the flow of blood during periods when dialysis is nottaking place. Using techniques which are well known, the fistula isinserted between a vein 120 and an artery 110. The dialysis valve 50, 60is only open when dialysis is occurring. As explained above, betweendialysis treatments the dialysis valve 50, 60 may be constrictedallowing a limited, increased velocity blood flow thereby preventing theformation of thrombus or clotting in the fistula. In other instances,the valve 50, 60 may be completely closed, preventing any blood flowbetween dialysis treatments.

Using the dialysis valve 50, 60 following successful surgicalimplantation first requires the physician locating the port 48 andmembrane 49 which are located beneath the patient's skin. Betweendialysis treatments an infusion needle 52 loaded with a saline solutionfirst punctures the patient's skin followed by puncturing the membrane49. The saline solution (not shown) is then injected under pressurethrough the port 48, hydraulic line 46, 64 and finally into the bellows44 or balloon 62. Saline is continued to be injected until the desireddegree of closure of the coated braid assembly 20 is achieved. When thenext dialysis treatment is to occur, the physician locates the port 48and membrane 49, inserts an infusion needle 52 and withdraws the salinesolution, resulting in the coated braid assembly 20 decreasing in itslongitudinal dimension 24 and increasing in diameter, thus resuming itsopen, default configuration.

Although the present invention has been described in considerable detailwith reference to certain preferred versions thereof, other versions arealso possible. Therefore, the spirit and scope of the appended claimsshould not be limited to the description of the preferred versionscontained herein.

What is claimed is:
 1. A method of controlling blood flow, comprising:inserting a self-sealing membrane of an implantable valve actuationapparatus adjacent to an underside of a skin region, the self-sealingmembrane configured to be punctured by an infusion needle; attaching ablood input graft to a blood vessel, the blood input graft in fluidcommunication with a flexible implantable tube portion coupled to theimplantable valve actuation apparatus, the flexible implantable tubeextending through a controllable valve actuation member and configuredto convey blood received by the blood input graft; attaching a bloodoutput graft to a blood vessel, the blood output graft in fluidcommunication with the flexible implantable tube to the implantablevalve actuation apparatus, the blood output graft configured to outputblood into an internal blood stream after a dialysis treatment; andadjusting the controllable valve actuation member to selectively changeblood flow through the flexible tube by delivering a pressurizedinjection of hydraulic fluid through the self-sealing membrane and intoa hydraulic port of the implantable valve actuation apparatus.
 2. Themethod of claim 1, wherein the self-sealing membrane is positionedbetween a hydraulic port of the implantable valve actuation apparatusand the skin region.
 3. The method of claim 1, wherein the flexibleimplantable tube comprises a flexible polymer material and a nitinolstructure.
 4. The method of claim 1, wherein the flexible implantabletube defines a substantially smooth inner surface.
 5. The method ofclaim 1, wherein the flexible implantable tube portion comprises abraided structure.
 6. The method of claim 1, wherein delivering apressurized injection of hydraulic fluid comprises penetrating theself-sealing membrane of the implantable valve actuation apparatus withan infusion needle.
 7. The method of claim 1, further comprisingwithdrawing the hydraulic fluid from the hydraulic port using aninstrument that is penetrated through the self-sealing membrane.
 8. Themethod of claim 7, comprising, in response to said withdrawing of thehydraulic fluid from the hydraulic port, adjusting the controllablevalve actuation member so as to alter the flexible implantable tubeportion from a second configuration to an open configuration, whereinthe flexible implantable tube portion in the second configuration has adecreased diameter at a narrowed portion while not fully closing theflexible implantable tube portion.
 9. The method of claim 8, decreasinga blood flow rate through the flexible implantable tube portion of lessthan about 300 cc per minute when the flexible implantable tube portionreceives blood from the blood input graft.
 10. The method of claim 7,wherein the hydraulic fluid comprises saline.
 11. The method of claim 7,wherein the implantable valve actuation apparatus comprises a housingstructure that is implantable.
 12. The method of claim 11, wherein theflexible implantable tube portion extends through the housing structureof the implantable valve actuation apparatus, and the controllable valveactuation member is positioned in the housing structure of theimplantable valve actuation apparatus.
 13. The method of claim 1,further comprising: withdrawing the hydraulic fluid from the hydraulicport using an instrument that is penetrated through the self-sealingmembrane; and adjusting the controllable valve actuation member so as toalter the flexible implantable tube portion from a second configurationto an open configuration, wherein the flexible implantable tube portionin the second configuration is closed to prevent blood flow through theflexible implantable tube portion.
 14. The method of claim 1, whereinthe self-sealing membrane at least partially defines a wall of ahydraulic port of the implantable valve actuation apparatus such thatthe self-sealing membrane is positioned between the hydraulic port andthe skin region.
 15. A method of controlling blood flow, comprising:inserting a self-sealing membrane of an implantable valve actuationapparatus adjacent to an underside of a skin region such that theself-sealing membrane is configured to be repeatedly punctured by aninfusion needle; attaching a blood input graft to a blood vessel, theblood input graft in fluid communication with a flexible implantabletube coupled to the implantable valve actuation apparatus, the flexibleimplantable tube extending through a controllable valve actuation memberand configured to convey blood received by the blood input graft from ablood vessel; attaching a blood output graft to a blood vessel, theblood output graft in fluid communication with the flexible implantabletube; and adjusting the controllable valve actuation member toselectively alter the flexible implantable tube from an openconfiguration in which blood flows into the flexible implantable tube toa second configuration by delivering a pressurized injection ofhydraulic fluid through the self-sealing membrane and into a hydraulicport of the implantable valve actuation apparatus, wherein a diameter ofthe flexible implantable tube is decreased in the second configuration.16. The method of claim 15, wherein the self-sealing membrane ispositioned between a hydraulic port of the implantable valve actuationapparatus and the skin region.
 17. The method of claim 15, whereindelivering a pressurized injection of hydraulic fluid comprisespenetrating the self-sealing membrane of the implantable valve actuationapparatus with an infusion needle.
 18. The method of claim 17, whereinthe implantable valve actuation apparatus comprises a housing structurethat is implantable, the flexible implantable tube extends through thehousing structure of the implantable valve actuation apparatus, and thecontrollable valve actuation member is positioned in the housingstructure of the implantable valve actuation apparatus.
 19. The methodof claim 18, further comprising: withdrawing the hydraulic fluid fromthe hydraulic port using an instrument that is penetrated through theself-sealing membrane; and adjusting the controllable valve actuationmember so as to alter the flexible implantable tube from a secondconfiguration to the open configuration, wherein the flexibleimplantable tube in the second configuration is closed to prevent bloodflow through the flexible implantable tube.
 20. The method of claim 15,wherein the self-sealing membrane at least partially defines a wall of ahydraulic port of the implantable valve actuation apparatus such thatthe self-sealing membrane is positioned between the hydraulic port andthe skin region.